510(k) · Cleared
ClearedHalyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Owens & Minor (O&M) Halyard, Inc. · FYC Gown, Isolation, Surgical
Cleared on May 16, 2024 as substantially equivalent to K160361 (Primed Medical Products, Inc., 2016) after a 245-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- May 16, 2024
- Review
- 245 days
- Class
- Class II
- Product code
- FYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K981393 (1998). No later device cites it as a predicate yet.
- Root · 2 generations backK981393 Microcool Surgical GownKimberly-Clark Corp. · 1998
- 1 generation backK160361 PRIMAGARD Isolation Gown (AAMI PB70 Level 3)Primed Medical Products, Inc. · 2016
- This deviceK232849 Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard…Owens & Minor (O&M) Halyard, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981393 | Microcool Surgical Gown | Kimberly-Clark Corp. | 1998 | — |
| −1 | K160361 | PRIMAGARD Isolation Gown (AAMI PB70 Level 3) | Primed Medical Products, Inc. | 2016 | — |
| 0 (this device) | K232849 | Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer… | Owens & Minor (O&M) Halyard, Inc. | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FYC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FYC device
- #1 K190306 AMD Ritmed AssureWear VersaGownscore 14.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160361 | PRIMAGARD Isolation Gown (AAMI PB70 Level 3)Summary page 5…Device Classification: Class II FDA Device Name: Gown, Isolation, Surgical FDA Regulation Number: 21 CFR 878.4040 Predicate Device: K160361 – PRIMAGARD AAMI PB70:2012 Level 3 gowns Device Descriptions:… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 18.3 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K160361.
How does its category compare?
All FYC devicesFYC Gown, Isolation, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · FYC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FYC
95in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FYC
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FYC
3in 2025
MAUDE reports naming product code FYC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 7 | 182 | 0 | 0 |
| 2022 | 10 | 229 | 0 | 0 |
| 2023 | 4 | 95 | 0 | 1 |
| 2024 | 1 | — | 2 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Halyard Tri-Layer AAMI 3 Isolation Gowns are intended to be worn by healthcare personnel in isolation applications to provide moderate barrier protection for healthcare personnel and patients from microorganism transfer, body fluids, and particulate matter. The gowns are non-sterile, single use, and meet AAMI PB70:2012 level 3 Liquid Barrier performance requirements. Not intended for use in the operating room.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232849 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232849: Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232849
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026